Clinical Trial: IL-2 for Multi Drug Resistant Nephrotic Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of IL-2 for Pediatric, Multi Drug Resistant, Idiopathic Nephrotic Syndrome

Brief Summary:

The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic nephropathy:

cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle.

cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle.

Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle.

Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during the first cycle and progressively reduced during the subsequent cycles.

The first cycle will be performed during hospitalization in the investigators Unit; subsequent cycles will be performed at nephrology outpatients. All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol, together with specific cellular values (Tregs, B cells, NK).


Detailed Summary:
Sponsor: Istituto Giannina Gaslini

Current Primary Outcome: Proteinuria [ Time Frame: Change from baseline at 30, 60 and 180 days after first cycle (5 days) ]

Complete remission is defined by urinary protein/creatinine ratio (uPCR) <200 mg/g (<20mg/mmol) for 3 consecutive days. Partial remission is defined as proteinuria reduction of 50% or greater from the presenting value and absolute uPCR between 200 and 2000 mg/g. for 3 consecutive days.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tregs Levels [ Time Frame: Immediately before first cycle and 30, 60 and 180 days after first cycle (5 days) ]
  • Serum Creatinine [ Time Frame: Change from baseline at 30, 60 and 180 days after first cycle (5 days) ]
  • Adverse events [ Time Frame: From day 1 to day 5 of each cycle. The study includes 5 cycles, each one lasting 5 days. ]


Original Secondary Outcome: Same as current

Information By: Istituto Giannina Gaslini

Dates:
Date Received: May 13, 2015
Date Started: February 2012
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015